Tuesday, April 29, 2014

Impact Of SVR On Liver Fibrosis and Cirrhosis

New Drugs Less Side Effects

The liver conference this month was all about new and investigational HCV oral regimens, many even close to FDA approval.

The long awaited revolution in HCV treatment has arrived, we are seeing improved cure rates, safety, and tolerability across many different patient populations and HCV genotypes. Finally, treating HCV without interferon has spared some patients from those debilitating side effects, but more importantly should open the door to treatment for people who are unable to tolerate interferon, or on the fence about starting treatment.

Gilead's Sovaldi (sofosbuvir) was approved last year for HCV genotypes 1 and 4 in combination with PEG-IFN/ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. Gilead remains high on the list of game-changers and has demonstrated astounding cure rates in 8 to 12 weeks with other sofosbuvir based regimens.  AbbVie's new antiviral agents ABT-450/r–Ombitasvir and Dasabuvir is also showing high SVR rates among difficult to treat patients in 12 and 24 week regimens. Here is an excerpt from the original article published this month in the New England Journal Of Medicine; ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis 

"...this multitargeted approach combining ritonavir-enhanced ABT-450 with ombitasvir, dasabuvir, and ribavirin resulted in rates of sustained virologic response at post-treatment week 12 of 92% with a 12-week regimen and 96% with a 24-week regimen, with a low rate of treatment discontinuation, among both previously untreated and previously treated patients with HCV genotype 1 infection and compensated cirrhosis, a group at risk for liver-related illness and death."

Treatment Challenges

As the therapeutic landscape for hepatitis C is changing, treatment challenges for patients is improving. For instance just a few years ago some patients considered the side effects of treatment much more detrimental then the disease itself. Triple therapy which includes interferon and either boceprevir or telaprevir proved difficult, with new side effects reported, the most serious being telaprevir's rash.

Another huge challenge in past was getting people tested for the virus, still is. In 2012 HCV testing strategies were put in place by the CDC and according to the agency, out of the three million Americans living with hepatitis C close to 75 percent have no idea they are infected – placing them at serious risk for liver disease, cancer, and death. The problem is so serious that in June 2013, the US Preventive Services Task Force followed suit and endorsed that recommendation by giving the one-time test of baby-boomers a "B" rating, which allows for payment by Medicare and private insurers for testing with no copayment by patients. If you were born during 1945-1965, talk to your doctor about getting tested for hepatitis C.  Baby boomers are five times more likely than other adults to be  infected. 

Impact Of SVR On Liver Fibrosis and Cirrhosis

With improved therapies and better awareness in place the virus is getting treated and not a moment too soon. As research continues to demonstrate achieving SVR can prevent liver cancer and improve or even reverse serious disease complications such as fibrosis, and cirrhosis. As seen in recent literature published in the Journal of Hepatology and Liver International investigating the effect of SVR (synonymous with virological cure) on disease progression.

We begin with this October 2013 study published in Journal of Hepatology; Slow regression of liver fibrosis presumed by repeated biomarkers after virological cure in patients with chronic hepatitis C

The aim of this study is to evaluate the impact of SVR on liver fibrosis over a 10-year period.

In the cohort of 933 patients;
415 patients had advanced fibrosis at baseline
108 attained SVR
219 were nonresponders and 88 were not treated.

The percentage with regression of fibrosis
49 in patients with SVR
23 in nonresponders and 45 in untreated

Cirrhosis regressed in 24 of the 43 patients with SVR, but 15 new cases with cirrhosis occurred out of 128 patients without cirrhosis at baseline.

In patients with chronic hepatitis C, and as presumed by FibroTest™, virological cure was associated with slow regression of fibrosis 10 years later, a disappointing 5% decrease in cirrhosis cases, and a remaining 5% risk of primary liver cancer.

Please click on the links for a more detailed information.

In a literature review published this month in Liver International; Cirrhosis Regression in Hepatitis C Patients with Sustained Virologic Response after Anti-Viral therapy: A Meta-analysis, researchers set out to find the association between SVR and cirrhosis regression.

A systematic literature search was performed to identify studies that assessed the association between SVR and cirrhosis regression. The main outcome studied was cirrhosis regression in patients with a SVR as compared to patients without a SVR.

Six studies totaling 443 patients were included;
Of the 443 patients with cirrhosis, 137 achieved a SVR.

The percentage with regression of cirrhosis
Of these 137 patients who achieved an SVR, 73 (53%) patients had regression of cirrhosis. 

Our results suggest that the majority of patients with cirrhosis who achieve a SVR develop cirrhosis regression. Time between biopsies appears to be an important determinant of the likelihood of cirrhosis regression.

Please click on the links for a more detailed information.

Stay hopeful my friends, with so many extremely effective new drugs moving quickly through the development process,  "your" cure will be within reach, sooner than later.

Safe healthy and safe.


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